Objective: Is proactive integrated care costeffective and does it result in better patients experience than usual care after 12 months for patients with problems on multiple life domains?This study will focus on measuring the changes in the…
ID
Source
Brief title
Condition
- Other condition
- Economic and housing issues
Synonym
Health condition
Multi-morbiditeit (psychisch, sociaal en somatisch)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is incremental cost-effectiveness. To measure this
outcome data sources will be used and linked at the individual level. At the
start of the study (t=0) and at the end (t=22) data on care usage and costs
will be collected. These data will be translated into cost using standard cost
prices from the Dutch guideline for economic evaluations.
Secondary outcome
1.Patient experience of care
The secondary study parameter is insight into the patient experience of care.
To assess their experience focus groups will be organized. Four main topics
will be discussed, namely: care before the new approach, the new approach, the
collaboration between the professionals and the experienced effects of the new
approach. Furthermore, information about self-efficacy (PAM-13 and SE+IN
itemlist), proactive coping (UPCC), and quality of life (SF-12) will be
collected using questionnaires
2.Process evaluation
A process evaluation of this study will be done simultaneously, as a process
evaluation can provide valuable insight on the practicalities of the
intervention. Data on recruitment and reach of the population will be gathered
during the inclusion of patiens in this study. Information on integration of
care with the social domain and the mental domain will also be gathered.
Additional questionnaires will be gathered about patient satisfaction with
care, using a modified version of the NPS (Reichheld, 2003). The nature of the
communication between care professional and patient, will be assessed using a
HCCQ questionnaire (Jochems, Duivenvoorden, van der Feltz-Cornelis, & van Dam,
2014; Czajkowska, Wang, Hall, Sewitch, & Körner, 2017). Furthermore, a
questionnaire will be used combining the assessment of the acceptability
(Acceptability of Intervention Measure - AIM), appropriateness (Intervention
Appropriateness Measure - IAM), feasibility (Feasibility of Intervention
Measure - FIM), and perceived and experienced effectiveness of the intervention
(Weiner, Lewis, & Stanick, 2017).
Background summary
Hotspotters have complex problems on multiple life domains, treated with
expensive fragmented care which is difficult to manage by patients and care
providers, leading to little effect of the care and persistent unmet needs. The
accumulation of problems within hotspotters is related to high medical
expenses. Next to their high medical spending levels, hotspotters experiences
with the healthcare system are low as the healthcare system is not (yet)
successful in dealing with their needs. This group places a lot of strain on
healthcare professionals since their problems require a multidisciplinary
supply of healthcare services, often in combination with social care and
welfare. The term *hotspotters *was first introduced in Gawande*s landmark
article. He suggested that the accumulation of problems and high hospital costs
were concentrated in certain areas (also defined as *hot spots*) in Camden, New
Jersey. When looking at medical care data he noticed that there was a small
group of people located in these areas, who accounted for most of the medical
costs. Up until now, a proper evaluations of the treatment (proactive
integrated care) in the *hotspotter* group yield undecisive conclusions.
Interventions aimed at the complex situation of hotspotters in our current
healthcare system might benefit by applying The Triple Aim approach. This
approach aims to improve the individual experience of care, reduce the cost of
care per capita and improve the health of populations.
Study objective
Objective: Is proactive integrated care costeffective and does it result in
better patients experience than usual care after 12 months for patients with
problems on multiple life domains?
This study will focus on measuring the changes in the following:
1. Incremental cost-effectiveness from a societal perspective. Information on
cost will be based on patient-reported data obtained by questionnaires supplied
with data from the GP medical files (Huisarts informatie system, HIS) and
CBSmicrodata. To assess the effectiveness the EQ-5D-5L will be used for
determining quality of life.
The secondary study parameters are:
1. Insight into patients experience of care, quality of life, proactive coping,
and self-efficacy. This information will be gathered using interviews, focus
groups and questionnaires (SF-12, UPCC, PAM-13 & Self-efficacy and Intentie
itemlist).
2. Process evaluation with the involved care professionals, including the
integration level of care per GP-practice, the nature of the communication
between healthcare provider and patient (HCCQ, OPTION5), and acceptability
(AIM), appropriateness (IAM), feasibility (FIM) ,and perceived and experienced
effectiveness of the intervention.
Study design
We will use a stepped-wedge randomised controlled trial (RCT) design (Hemming,
Haines, Chilton, Girling ,& Lilford, 2015). This design involves random and
sequential crossover of groups from control to intervention until all groups
are exposed to the intervention. A stepped wedge cluster RCT is especially
useful when the intervention is thought to do more good than harm (i.e.,when
there is no equipoise). In that situation, it is unethical to withhold or
withdraw the intervention from a proportion of the subjects as would occur in a
parallel group or classic cluster RCT. Besides, it may be impossible to
implement the intervention in half of all clusters simultaneously because of
practical, logistical, or financial reasons, which is also the case in the
current study with regard to the practical and logistical reasons. Then, the
stepwise treatment implementation of the stepped wedge design offers a
solution. Since all patients included in this study will be offered the
intervention, which may contribute to limiting lost to follow-up
The personalized approach, local collaborations with the social domain and
organizational differences between general practices will result in nuanced
differences in how our intervention will be applied. Besides, training the
Positive Health methodology and the enhanced collaboration between domains most
likely effects patients not-offered the intervention as well. Randomisation
will therefore be done by cluster.
This study will be performed in 20 general practices. Each practice will form
one cluster. We aim to include an average of 10 patients per cluster. A GP or
POH-GGZ can only participate in one cluster. The terms GP practice and cluster
will be used alternatively and exchangeable form this point on, both referring
to the given description.
Each participating patient starts with a control period and will cross-over to
the intervention period. The control period varies between 2 to 8 months. All
patients from a GP practice cross-over at the same moment. Therefore the
GP-practices are randomized into one of four groups.
All clusters start to collect control data at the same time ( t=0). The 20
clusters will be divided into four groups evenly and each group will be
randomly assigned one of four time points at which they will start to implement
the proactive integrated care intervention. The first switch will be after 2
months (t=2). Every subsequent 2 months a next group of general practices will
switch to the intervention mode until all groups have started the intervention.
All groups will continue with the intervention as described in this protocol
for a total of 12 months. After the 12 months of intervention, care will be
delivered as usual. There is no objection if care providers and patients wish
to maintain certain aspects of the intervention. All measurements and
timepoints after the switch to the intervention falls under the intervention
period. The total duration of this study comprises 22 months. This results in
varying control period ranging from 2 to 8 months. The total of intervention
and follow-up period vary from 14 to 20 months. This time table is summarized
in the following chart. In order to achieve more accurate answers from patients
and in turn more reliable results, a member of the research team will
administer the SF-12, and questionnaires on proactive coping (UPCC), and
self-efficacy (PAM-13 and SE+IN) during a face to face interview, as these
might require extra guidance when filling in. This will be done at three time
points for each group (before the start of the intervention, at the end of the
intervention, and two months after the intervention has ended).
Intervention
The proactive integrated care intervention that will be used consists of five
steps:
1. Active invitation of the patient from the practice
2. Consult of 45 minutes with a trained Practice Nurse Mental Health Care based
on the Positive Health Methodology. The outcome of this consultation is a
spiderweb with an overview of current health status according to positive
health methodology.
3. Multidisciplinary Team meeting (MDO) based on the spider web with the domain
specific explanation. In this MDO at least the mental health practice nurse,
GP, social worker or community nurse are present. The patient is always
invited. The outcome of this meeting is: (1) a personalised care plan; (2)
appointment of one care coordinator and (3) a structured follow up plan
(frequency and duration) of the progression of this patient*s problems.
4. Execution of the personalised care plan. The care coordinator has frequent
contact with the patient. A minimum of 3 consultations for the first 12 weeks
is set, however more frequent consultation can be expected. The proactive
nature of this contact is emphasized. A minimum of 4 consultations between
patient and care coordinator is set.
5. Follow-up of the personalised care plan. During the regular monthly meetings
of the health and social care network the follow-up of the patients will be
reviewed. Each patient will be discussed at least two times, but more often if
necessary. In case the care plan is not followed correctly or it does not have
the desired outcome, the patient and
Study burden and risks
Participation in this study is expected to be low risk for the patients.
However, both risks and benefits are associated with participation.
Benefits include:
Improved knowledge and insight: Participation might lead patients to have a
better understanding of the factors that contribute to their overall
well-being. This can be achieved with analysing the six life domains of the
positive health conversation tool. This insight might result in appropriate
interventions that meet the needs of the hotspotters.
A potential risk that should be taken into account is:
(temporary) Elevated stress: hotspotters* experience a combination of different
problems which can make life more complex and challenging. Participation could
results in more stress in some participants (especially in the beginning) due
to the heightened emphasis on the factors that contribute to their health and
social problems.
Trufmarkt 99
Den Haag 2511DV
NL
Trufmarkt 99
Den Haag 2511DV
NL
Listed location countries
Age
Inclusion criteria
-The patients are >= 18yrs
-The patients are registered within one of the participating GP practices.
-Patients with at least two acute care encounters in the past 12 months. Acute
care encounter is defined as an encounter with out-of-hours GP service,
emergency care or acute mental health care.
-Patients have problems registered in the GP Information system on at least two
out of three of the following domains: somatic, mental or social.
Exclusion criteria
- The patient is terminal.
- The patient is living in a residential home.
- The patient has dementia or a disability that prevents them from
communicating effectively.
- The patients opt out for permission to use medical data
- The patient already has experience with the positive health tool.
- The patient is not competent to make decisions concerning their health. This
wil be assessed by the patient*s own general practitioner.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
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CCMO | NL78646.058.21 |